Search Results for keywords:"Regulatory Compliance"

The Environmental Protection Agency (EPA) is proposing to approve a revision to New York's State Implementation Plan (SIP) to reduce nitrogen oxide (NOx) emissions from certain combustion turbines during the ozone season. The revision includes stricter emission limits aimed at improving air quality and meeting federal ozone standards. New York's approach involves phasing in the new limits and offers flexibility to turbine operators through two compliance options. This proposal is part of ongoing efforts to clear harmful pollutants and protect public health by ensuring states adhere to the Clean Air Act.

The Coast Guard is making corrections to a rule that was published in the Federal Register on November 25, 2024. This rule requires Coast Guard-approved training providers to submit course completion data electronically within 5 business days and introduces some editorial changes. However, the document had four errors that needed fixing, which are addressed in this correction. The corrections are effective on January 17, 2025, and involve updates to various sections and instructions in the original document.

The Environmental Protection Agency (EPA) has asked for approval to extend an information collection request for the National Emission Standards for Hazardous Air Pollutants (NESHAP) for Secondary Lead Smelter Industry. This extension is needed to ensure compliance with regulations that affect entities recovering lead from materials like used car batteries. Public comments about this proposal can be sent until March 31, 2025. The estimated cost of these activities is $2,750,000 per year, involving around 19,900 hours of work from 11 facilities.

The Veterans Benefits Administration (VBA) of the Department of Veterans Affairs has announced that it will submit an information collection to the Office of Management and Budget (OMB) for review, in compliance with the Paperwork Reduction Act. The information collection, titled "Monthly Certification of On-The-Job and Apprenticeship Training," uses VA Forms 22-6553d-1 and 22-6553d to determine benefits based on the trainee's hours worked, verified by the training establishment. The submission is a revision of a currently approved collection and is no longer required to be signed by the trainee due to amendments made by the Veterans Apprenticeship and Labor Opportunity Reform Act. The VBA invites comments on this information collection within 30 days of the notice's publication date.

The U.S. Department of Energy (DOE) has issued a final rule clarifying the test procedures for general service lamps (GSLs). These clarifications emphasize that GSLs shouldn't be tested as colored lamps, and if a lamp includes extra components not affecting light output, those components should be turned off during tests. For non-integrated lamps, the rule specifies testing with a ballast or driver that's compatible and commercially available, where possible. The final rule is designed to ensure consistent testing without imposing additional costs or burdens on manufacturers.

The Food and Drug Administration (FDA) is inviting public feedback on its proposed collection of information related to adverse events and product experiences for FDA-regulated products. As part of fulfilling requirements under the Paperwork Reduction Act, the FDA seeks comments on whether this information collection is necessary, its accuracy, and ways to minimize the burden on respondents. They have updated forms and processes to standardize data collection, improve quality and clarity, and ensure confidentiality where necessary. The deadline for providing comments, either electronically or by mail, is March 18, 2025.

The Food and Drug Administration (FDA) has released a draft guidance document titled "M15 General Principles for Model-Informed Drug Development." This document was created under the International Council for Harmonisation (ICH) and provides recommendations on planning, evaluating, and documenting evidence in drug development using models. It aims to help harmonize regulations globally, enhancing drug development and improving manufacturing standards. Public comments on the draft can be submitted until February 28, 2025.

The U.S. Department of Housing and Urban Development (HUD) has extended the compliance date for its final rule under the Housing Opportunity Through Modernization Act (HOTMA) for certain Community Planning and Development (CPD) programs until January 1, 2026. This extension is due to delays in updating HUD systems and aims to give grantees more time to incorporate the necessary changes. HUD is also allowing the use of income safe harbor provisions established in the HOTMA rule before the new compliance date. These changes affect programs like the HOME Investment Partnerships program, Housing Trust Fund, and others, allowing grantees flexibility in transitioning to new requirements.

The FDA is withdrawing approval for 12 new drug applications (NDAs) because the drugs are no longer being sold, and the companies that own them have requested this action. The approval withdrawal, effective February 14, 2025, affects all parts of the applications, including any dosage forms or strengths. Any remaining stock of these drugs can be sold until it is gone or expires.

The Securities and Exchange Commission (SEC) has approved a rule change proposed by MIAX PEARL, LLC to amend its By-Laws to align with an Equity Rights Program (ERP). This change allows certain exchange members to nominate or appoint a representative to the MIAX PEARL Board of Directors if they meet specified criteria and thresholds in trading volume and exchange fees over a set period. ERP members will have the opportunity to nominate a director or appoint an observer with non-voting rights to the board, providing greater representation for those active in trading. These adjustments maintain compliance with regulatory requirements, ensure fair representation, and preserve the board's composition and duties.